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510(k) K140846

EDS COMBO-RINSE by Essential Dental Systems, Inc. — Product Code KJJ

K140846 is an FDA 510(k) premarket notification submitted by Essential Dental Systems, Inc. for the device "EDS COMBO-RINSE". The FDA issued a decision of Substantially Equivalent on July 25, 2014. The device falls under product code KJJ (Cleanser, Root Canal), a Class U device. Essential Dental Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 25, 2014
Date Received
April 3, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cleanser, Root Canal
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Essential Dental Systems, Inc.

  • K223340 — EDS Calculus Softener TURBO CR (December 11, 2023)
  • K202281 — EDS Bioceramic Sealer (Bioseal) (February 12, 2021)
  • K152691 — EDS Universal Cement (February 25, 2016)
  • K132609 — EDS ULTRASONIC TIPS (January 22, 2014)
  • K111541 — ENDO-EXPRESS (R) HANDPIECE (March 16, 2012)
  • K101504 — TI-CORE FLOW (October 29, 2010)
  • K072555 — EDTA PLUS (December 13, 2007)
  • K070401 — ENDO-CHX (July 11, 2007)
  • K063856 — EZ-FILL XPRESS EPOXY ROOT CANAL CEMENT SYSTEM (February 6, 2007)
  • K943475 — ULTRA HYDROPHILIC ALGINAE (August 12, 1994)

Other clearances for product code KJJ

  • K250279 — RC-SwiftPrep (July 2, 2025)
  • K241354 — Sealer Solvent (August 27, 2024)
  • K201785 — EPIEN Dental Cleanser (September 9, 2021)
  • K211813 — Triton (August 18, 2021)
  • K193357 — V-Mix (October 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K200330 — RC-Prime Root Canal Preparation Cream (July 6, 2020)
  • K173163 — ChlorCid, ChlorCid V, ChlorCid Surf (February 9, 2018)
  • K162311 — Straumann PrefGel (March 7, 2017)
  • K160577 — PacEndo Chlorhexidine (July 25, 2016)

FDA data resources